TAXOL: FDA Approves First Generic Version of Cancer Drug
Ivax Corp. last week won FDA approval for its generic version of the blockbuster cancer drug Taxol, a move that promises breast and ovarian cancer patients much less expensive therapy. The Miami-based manufacturer said it expects to begin marketing the drug, paclitaxel, "in a matter of weeks." Ivax has been developing a generic version of Taxol for nearly a decade and won tentative approval to market the drug in August, but the company has been waiting for resolution of "complex patent litigation" and legal disputes involving Taxol maker Bristol-Myers Squibb and the small biotech firm American BioScience (Hensley/Lueck, Wall Street Journal, 9/18). Last week, a federal appeals court in California "lifted [Ivax's] last legal hurdle," a patent request that would have delayed generic competition for another 30 months. An Ivax spokesperson said the generic drug would be sold at a "significantly reduced price," noting that generic drugs typically cost 30% less than their brand-name counterparts. Currently, Taxol costs between about $5,000 to $7,000 per treatment course, depending on the patient's condition (Houston Chronicle, 9/16).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.